Virtual Lifestyle Medicine Comparative Effectiveness Research

NCT03731481 | Completed

• 1 other identifier: 17-X-166
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of two online Lifestyle Medicine programs. Participants will be randomized by residence, urban vs. rural, into one of two Lifestyle Medicine programs.

Conditions

Chronic Disease; Obesity; Sleep Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Level of participant engagement

  Measure of number of sign-ins and class attendance

  6 months

Secondary Outcomes (2)

• Chronic disease status

  Baseline, 5-weeks, and 6-months from baseline

• Psychological status

  Baseline, 5-weeks, and 6-months from baseline

Study Arms (4)

CHIP - Urban

EXPERIMENTAL

Participants randomized by urban location of residence to receive CHIP Lifestyle Medicine program intervention.

Behavioral: Lifestyle Medicine

CHIP - Rural

EXPERIMENTAL

Participants randomized by rural location of residence to receive CHIP Lifestyle Medicine program intervention.

Behavioral: Lifestyle Medicine

FPD2- Urban

EXPERIMENTAL

Participants randomized by urban location of residence to receive FPD2 Lifestyle Medicine program intervention.

Behavioral: Lifestyle Medicine

FPD2 - Rural

EXPERIMENTAL

Participants randomized by rural location of residence to receive FPD2 Lifestyle Medicine program intervention.

Behavioral: Lifestyle Medicine

Interventions

Lifestyle Medicine BEHAVIORAL

Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.

CHIP - Rural; CHIP - Urban; FPD2 - Rural; FPD2- Urban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to read and write English
• Access to high-speed Internet
• Taking medication for at least one chronic disease condition such as high blood pressure, OR are overweight (BMI of 25 or greater)
• Willing to provide blood samples at three time points
• Willing to complete online surveys at three time points

You may not qualify if:

• Advised by physician to limit physical activity
• Previous experience with lifestyle medicine programs, specifically Lifestyle Medicine Clinic, Complete Health Improvement Program, Full Plate Diet
• Household includes someone who has previous experience with a Lifestyle Medicine program

Sponsors & Collaborators

• Ohio University: lead
• Live Healthy Appalachia: collaborator
• Ardmore Institute of Health: collaborator
• OhioHealth: collaborator
• Lifestyle Medicine Institute: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Chronic Disease; Obesity; Sleep Wake Disorders; Depression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• David Drozek, DO

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, Heritage College of Osteopathic Medicine

Model Details: Comparative effectiveness research of two interventions across four cohorts

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 6, 2018
• Study Start: May 31, 2017
• Primary Completion: February 28, 2018
• Study Completion: July 1, 2018
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)